After August 1, new edit " medical apparatus and instruments classifies catalog " carry out, in view of at present still many citizens and enterprise still put question to its, explain as follows now
1
National provision medicines and chemical reagents supervises administrative total bureau to was released formally in August 2017 before new edit " medical apparatus and instruments classifies catalog " , set to be carried out since August 1, 2018 oneself;
2
New " classified catalog " it is 22 stature catalog according to major of technology of medical apparatus and instruments and cent of clinical use characteristic, subdirectory is described by category of product of category of one form product, 2 form, product, anticipate citing of utility, the name of an article and administrative category are comprised. When sentencing category of a system of fixed quotas for grain production to fasten, ought to the actual condition according to the product, union is new " classified catalog " in product description, anticipate utility and citing of the name of an article undertake deciding integratedly.
3
Total bureau of supervisory government of medicines and chemical reagents of provision of the state before the basis asks in public in September 2017 outgoing message (total bureau about carrying out " medical apparatus and instruments classifies catalog " the announce 〔 of concerned item 2017 the 143rd 〕 ) , since August 1, 2018, new business certificate of extending medical apparatus and instruments and the 2nd kind of medical apparatus and instruments are managed put on record the scope of operations of the proof ought to be divided into former " classified catalog " classified code area and new " classified catalog " classified code area, mark clearly. Scope of operations fills in subdirectory category. Scope of operations of code of classification of new old version must not be mixed make up, after waiting for what overall product all classifies encode for new edition product to register card, no longer divisional (reagent product category is diagnosed outside body ought to according to " reagent is diagnosed to register administrative measure outside body " (total bureau of supervisory government of national provision medicines and chemical reagents makes the 5th, the following abbreviation 5 order) , " reagent is diagnosed to register administrative measure amendment outside body " (total bureau makes the 30th, the following abbreviation 30 order) , " reagent is diagnosed to classify subdirectory outside 6840 body (2013 edition) " the classification that reagent diagnoses outside body is being concerned in reaching the classification that sequel releases to limit a file limits an opinion to undertake deciding, classified code continues to delay with 6840. )
If citizen or enterprise apply for, on application form " scope of operations " column should go up according to the picture indication example fills in, attention, on check scheme fill in to be example only, place of specific management breed belongs to the enterprise the category should inquire classified catalog by oneself.
4
Since August 1, 2018, outside eliminating put oneself in another's position, diagnose reagent category and " about issueing the give public notice of catalogue item of the first kind of medical apparatus and instruments " (announcement of total bureau of supervisory government of national provision medicines and chemical reagents 2014 the 8th) , " the announcement that food medicines and chemical reagents superintends total bureau general office to concern item about carrying out the first kind of medical apparatus and instruments to put on record " (, former " medical apparatus and instruments classifies catalog " (2002 〕 of 〔 of instrument of inspect of traditional Chinese medicine 302, the following abbreviation former " classified catalog " ) reach classify toward issuance medical apparatus and instruments already limit file content and catalog to abolish.
Relevant link:
1. (new directory downloads) the announcement that total bureau classifies catalog about releasing medical apparatus and instruments (2017 the 104th) :
Http://samr.cfda.gov.cn/WS01/CL0087/177089.html
2. total bureau about carrying out " medical apparatus and instruments classifies catalog " the announce of concerned item (2017 the 143rd) :
Http://samr.cfda.gov.cn/WS01/CL0087/177087.html
3.2002 years version classifies catalog online inquiry:
Http://samr.sda.gov.cn/gyx02302/flml.htm
